BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    INNOVATIVE TOMOGRAPHY PRODUCTS GMBH

    Reg #: 3014408997 · FEI: 3014408997 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    28
    Establishment Types
    5
    Classifications
    3

    Registration Details

    Registration Name
    INNOVATIVE TOMOGRAPHY PRODUCTS GMBH
    Registration Number
    3014408997
    FEI Number
    3014408997
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Universitaetsstrasse 136
    City
    Bochum North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K222462

    Owner / Operator

    Firm Name
    Innovative Tomography Products GmbH
    Operator Number
    10057613
    Address
    Universitaetsstrasse 136
    City
    Bochum
    State
    North Rhine-Westphalia
    Postal Code
    44799
    Country
    DE
    Correspondent
    Heinz-Werner Henke

    US Agent

    Business Name
    Dawa Medical LLC
    Contact Name
    Stephan Toupin
    Address
    7320 NW 12th Street, Suite 103
    City
    Miami
    State
    FL
    ZIP
    33126
    Country
    US
    Email
    [email protected]
    Phone
    786 7311159

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Marker, Skin FZZ
    Needle, Aspiration And Injection, Disposable GAA

    Proprietary Names

    KIM16/14T KIM18/15 KIM18/10 KIM18/15T KIM15/14T KIM13/14T KIM16/09T Coaxial Interventional Needle KIM KIM15/04T KIM18/20 KIM15/09T KIM22/10 KIM13/09T KIM22/05 KIM16/04T KIM22/15 KIM22/07 KIM13/04T KIM20/15 KIM14/20:T KIM20/10 KIM 20/20 KIM 25/03N KIM 15/36:90 KIR 17/20 Coaxial Interventional Needle KIR KIR 17/15 Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device